HyperlipidemiasPhase 1NCT03586037
Evaluating the Pharmacokinetic Interaction Between AD-2011 and AD-2012
A Phase 1 study testing AD-2011 10/20 mg, AD-2012 80mg and AD-2011 10/20 mg + AD-2012 80mg in people with Hyperlipidemias and Hypertension, run by Addpharma Inc. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2011 and AD-2012 in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemias, Hypertension
- What is being tested?
- AD-2011 10/20 mg, AD-2012 80mg and AD-2011 10/20 mg + AD-2012 80mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jun 2018to 20 Aug 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male between 19 and 50 years of age at the time of screening
- Weight between 50 kg and 90 kg and body mass index (BMI) between 18.0 kg/m2 and 27.0 kg/m2
Who cannot join
- Clinically significant disease or history of clinically significant disease such as liver, kidney, nervous system, respiratory, endocrine*hematologic, cardiovascular, urinary, psychiatric
- Gastrointestinal problem or history of gastrointestinal problem and history of gastrointestinal surgery
- AST, ALT values over than 1.5 times of ULN at screening
- HDL values less than 35 mg/dL
- A person who has a history of drug abuse or who has positive result for an abuse drug in a urine screening test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Sequence-randomized, Three-period, Six-sequence, Multiple Dosing Crossover Clinical Trial to Evaluate the Pharmacokinetic Interaction Between AD-2011 and AD-2012 in Healthy Male Volunteers
The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2011 and AD-2012 in healthy male volunteers.
Read the detailed description
To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the single administration of AD-2011 and AD-2012.
- Conditions
- Hyperlipidemias, Hypertension
- Being tested
- AD-2011 10/20 mg, AD-2012 80mg, AD-2011 10/20 mg + AD-2012 80mg
- Medical subject headings
- Hyperlipidemias, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-2011 10/20 mgDrug
AD-2011 10/20 mg tablet
AD-2012 80mgDrug
AD-2012 80mg tablet
AD-2011 10/20 mg + AD-2012 80mgDrug
AD-2011 10/20 mg + AD-2012 80mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Period 1: AD-2011 10/20mg QD Period 2: AD-2012 80mg QD Period 3: AD-2011 10/20mg + AD-2012 80mg QD Receives: Drug: AD-2011 10/20 mg; Drug: AD-2012 80mg; Drug: AD-2011 10/20 mg + AD-2012 80mg |
| Sequence 2 | Experimental | Period 1: AD-2011 10/20mg QD Period 2: AD-2011 10/20mg + AD-2012 80mg QD Period 3: AD-2012 80mg QD Receives: Drug: AD-2011 10/20 mg; Drug: AD-2012 80mg; Drug: AD-2011 10/20 mg + AD-2012 80mg |
| Sequence 3 | Experimental | Period 1: AD-2012 80mg QD Period 2: AD-2011 10/20mg + AD-2012 80mg QD Period 3: AD-2011 10/20mg QD Receives: Drug: AD-2011 10/20 mg; Drug: AD-2012 80mg; Drug: AD-2011 10/20 mg + AD-2012 80mg |
| Sequence 4 | Experimental | Period 1: AD-2012 80mg QD Period 2: AD-2011 10/20mg QD Period 3: AD-2011 10/20mg + AD-2012 80mg QD Receives: Drug: AD-2011 10/20 mg; Drug: AD-2012 80mg; Drug: AD-2011 10/20 mg + AD-2012 80mg |
| Sequence 5 | Experimental | Period 1: AD-2011 10/20mg + AD-2012 80mg QD Period 2: AD-2011 10/20mg QD Period 3: AD-2012 80mg QD Receives: Drug: AD-2011 10/20 mg; Drug: AD-2012 80mg; Drug: AD-2011 10/20 mg + AD-2012 80mg |
| Sequence 6 | Experimental | Period 1: AD-2011 10/20mg + AD-2012 80mg QD Period 2: AD-2012 80mg QD Period 3: AD-2011 10/20mg QD Receives: Drug: AD-2011 10/20 mg; Drug: AD-2012 80mg; Drug: AD-2011 10/20 mg + AD-2012 80mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration
Cmax of the total ingredient of AD-2011 and AD-2012
Measured: pre-dose to 24 hours
Area under the plasma concentration versus time curve
AUCtau of the total ingredient of AD-2011 and AD-2012
Measured: pre-dose to 24 hours
Secondary outcomes (6)
Time to reach Cmax
Tmax of the total ingredient of AD-2011 and AD-2012
Measured: pre-dose to 24 hours
Concentration
Ctrough of the total ingredient of AD-2011 and AD-2012
Measured: pre-dose to 24 hours
Elimination half-life
t1/2 of the total ingredient of AD-2011 and AD-2012
Measured: pre-dose to 24 hours
Clearance
CL/F of the total ingredient of AD-2011 and AD-2012
Measured: pre-dose to 24 hours
Volume of distribution
Vd/F of the total ingredient of AD-2011 and AD-2012
Measured: pre-dose to 24 hours
Number of participants with adverse events
Incidence rate of adverse events
Measured: From Day 1 up to Day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start12 Jun 2018
- Primary completion9 Aug 2018
- Study completion20 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiasStudies of the same condition, open and under way.
- More trials run by Addpharma Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addpharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- In-Jin Jang, M.D., Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586037
- Sponsor's protocol ID
- AD-201
- Status last verified
- Oct 2018
- First submitted
- 28 May 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huh KY, Lee SW, Lee SB, Kim KT, Jang IJ, Lee S. Pharmacokinetic Interaction Among Ezetimibe, Rosuvastatin, and Telmisartan. Clin Pharmacol Drug Dev. 2021 Nov;10(11):1290-1296. doi: 10.1002/cpdd.926. Epub 2021 Mar 1.
PubMed 33647189
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Sequence-randomized, Three-period, Six-sequence, Multiple Dosing Crossover Clinical Trial to Evaluate the Pharmacokinetic Interaction Between AD-2011 and AD-2012 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03586037
- Acronym / sponsor ID
- AD-201
- Conditions
- Hyperlipidemias, Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 9 Aug 2018 (actual)
- Study completion
- 20 Aug 2018 (actual)
- First posted
- 13 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2011 and AD-2012 in healthy male volunteers.
Detailed description
To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the single administration of AD-2011 and AD-2012.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: AD-2011 10/20 mg, Drug: AD-2012 80mg, Drug: AD-2011 10/20 mg + AD-2012 80mgPeriod 1: AD-2011 10/20mg QD Period 2: AD-2012 80mg QD Period 3: AD-2011 10/20mg + AD-2012 80mg QD |
| Sequence 2 | Experimental | Drug: AD-2011 10/20 mg, Drug: AD-2012 80mg, Drug: AD-2011 10/20 mg + AD-2012 80mgPeriod 1: AD-2011 10/20mg QD Period 2: AD-2011 10/20mg + AD-2012 80mg QD Period 3: AD-2012 80mg QD |
| Sequence 3 | Experimental | Drug: AD-2011 10/20 mg, Drug: AD-2012 80mg, Drug: AD-2011 10/20 mg + AD-2012 80mgPeriod 1: AD-2012 80mg QD Period 2: AD-2011 10/20mg + AD-2012 80mg QD Period 3: AD-2011 10/20mg QD |
| Sequence 4 | Experimental | Drug: AD-2011 10/20 mg, Drug: AD-2012 80mg, Drug: AD-2011 10/20 mg + AD-2012 80mgPeriod 1: AD-2012 80mg QD Period 2: AD-2011 10/20mg QD Period 3: AD-2011 10/20mg + AD-2012 80mg QD |
| Sequence 5 | Experimental | Drug: AD-2011 10/20 mg, Drug: AD-2012 80mg, Drug: AD-2011 10/20 mg + AD-2012 80mgPeriod 1: AD-2011 10/20mg + AD-2012 80mg QD Period 2: AD-2011 10/20mg QD Period 3: AD-2012 80mg QD |
| Sequence 6 | Experimental | Drug: AD-2011 10/20 mg, Drug: AD-2012 80mg, Drug: AD-2011 10/20 mg + AD-2012 80mgPeriod 1: AD-2011 10/20mg + AD-2012 80mg QD Period 2: AD-2012 80mg QD Period 3: AD-2011 10/20mg QD |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male between 19 and 50 years of age at the time of screening
- Weight between 50 kg and 90 kg and body mass index (BMI) between 18.0 kg/m2 and 27.0 kg/m2
Key exclusion criteria (5 listed)
- Clinically significant disease or history of clinically significant disease such as liver, kidney, nervous system, respiratory, endocrine*hematologic, cardiovascular, urinary, psychiatric
- Gastrointestinal problem or history of gastrointestinal problem and history of gastrointestinal surgery
- AST, ALT values over than 1.5 times of ULN at screening
- HDL values less than 35 mg/dL
- A person who has a history of drug abuse or who has positive result for an abuse drug in a urine screening test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AD-2011 10/20 mgAD-2011 10/20 mg tablet | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| AD-2012 80mgAD-2012 80mg tablet | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| AD-2011 10/20 mg + AD-2012 80mgAD-2011 10/20 mg + AD-2012 80mg tablet | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
Peak Plasma Concentration
Time frame: pre-dose to 24 hours
Cmax of the total ingredient of AD-2011 and AD-2012
Area under the plasma concentration versus time curve
Time frame: pre-dose to 24 hours
AUCtau of the total ingredient of AD-2011 and AD-2012
6 secondary outcomes
Time to reach Cmax
Time frame: pre-dose to 24 hours
Concentration
Time frame: pre-dose to 24 hours
Elimination half-life
Time frame: pre-dose to 24 hours
Clearance
Time frame: pre-dose to 24 hours
Volume of distribution
Time frame: pre-dose to 24 hours
Number of participants with adverse events
Time frame: From Day 1 up to Day 45
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Derived from this study: PubMed 33647189Huh KY, Lee SW, Lee SB, Kim KT, Jang IJ, Lee S. Pharmacokinetic Interaction Among Ezetimibe, Rosuvastatin, and Telmisartan. Clin Pharmacol Drug Dev. 2021 Nov;10(11):1290-1296. doi: 10.1002/cpdd.926. Epub 2021 Mar 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In-Jin Jang, M.D., Ph.D principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AD-2011 10/20 mg, AD-2012 80mg and AD-2011 10/20 mg + AD-2012 80mg in people with Hyperlipidemias and Hypertension, run by Addpharma Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (time frame: pre-dose to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03586037, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.